CellSure, L3C — FDA Facility Profile
CellSure, L3C is an FDA-inspected facility (FEI 3014621414) located in Salt Lake City, UT, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 8, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 8, 2023 | Voluntary Action Indicated (VAI) | Approve or reject procedures or specs (21 CFR 211.22(c)) Risk factors, clinical evidence (21 CFR 1271.75(a)(1)) Eligibility not required--warning labels (21 CFR 1271.90(c)) Lack of written stability program (21 CFR 211.166(a)) and 2 more |
| Aug 2, 2021 | Voluntary Action Indicated (VAI) | Procedures for all other requirements (21 CFR 1271.47(a)) Name and address on summary (21 CFR 1271.55(b)(3)) Shipped but not kept in quarantine (21 CFR 1271.60(c)) Risk factors, clinical evidence (21 CFR 1271.75(a)(1)) and 3 more |
Facility details
- Company
- CellSure, L3C
- Location
- Salt Lake City, UT (US)
- Source
- inspections